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Quality Coordinator

2 months ago

Mason, United States AtriCure Full time

Quality Coordinator Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America Req #2042 Thursday, May 9, 2024 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: This position will be responsible for ensuring the AtriCure Document Control System is in compliance with domestic and international medical device quality system regulations. The Quality Coordinator is able to answer daily quality questions to in regard to MasterControl and document control. In the role of the Quality Coordinator, this person will work with the entire AtriCure organization to ensure compliance with the AtriCure Quality System and will be responsible to report to management issues revolving around quality system compliance. ESSENTIAL FUNCTIONS OF THE POSITION: Responsible for processing Document Change Notices through the quality system Responsible for processing Data Control and Engineering Protocols and Reports through the quality system Responsible for Quality Systems Records filing, maintenance, and retention of all files (e.g. design history files, device history records, and other quality system records) per domestic and international regulatory requirements Assisting with execution of updates of ERP system following release of Document Change Notices Responsible for understanding and maintaining compliance with domestic and international medical device quality system regulations, where appropriate Responsible for complying with all document control processes within the AtriCure Quality System. Aide in finished product release activities as assigned Perform Quality System activities and other company activities in addition to the above as needed ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Ability to work under fast-paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: High School Diploma or GED Experience with inspection/testing Strong computer/data entry and communication skills with an emphasis on attention to details Problem solving/trouble shooting experience PREFERRED QUALIFICATIONS: Auditing Experience Read technical Specifications Read blueprints, drawings, specifications OTHER REQUIREMENTS: Ability to regularly walk, sit, or stand as needed Ability to occasionally bend and push/pull as needed Ability to pass pre-employment drug screen and background check AtriCure has a